Biocon Biologics clears path for Stelara Biosimilar in major markets 


Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has secured market entry for its proposed biosimilar to Stelara in Europe, the UK, Canada, and Japan. The company announced today, that it has signed a settlement and license agreement with Janssen, resolving patent disputes for its product Bmab 1200 (bUstekinumab).

The shares of Biocon Ltd were trading at ₹355.40 down by ₹1.30 or 0.36 per cent today on the NSE at 10:30 am

This agreement follows a similar settlement in the United States, where Biocon Biologics plans to launch no later than February 22, 2025, pending FDA approval. The US FDA has already accepted the company’s Biologics License Application for review.

Bmab 1200 is a biosimilar to Ustekinumab, a monoclonal antibody used to treat various autoimmune diseases. The reference brand, Stelara, reported worldwide sales of $10.85 billion in 2023.

Shreehas Tambe, CEO & Managing Director of Biocon Biologics stated, “Bmab 1200 will significantly strengthen our immunology franchise, enabling us to offer an affordable and effective treatment option for patients impacted by autoimmune diseases.”